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Re: FDA intereference costs lives
From: Dona (anonymous@obgyn.net)
Sat, 17 Nov 2001 21:16:40 -0600 (CST)
Actually they have to sign an informed consent of the risks .Sorry this
got so off topic. Thanks,Dona
>
>Another one I haven't been able to send for several days:
>
>It actually is very effective for the diseases you mentioned: HIV, leprosy
>(aka Hansen's disease), etc.
>
>However, remember that people with these diseases have to use good birth
>control to prevent problems with the child from the disease. Anyone
>prescribing, or using, Thalidomide has to understand the risk and use only in
>people who won't be childbearing for one reason or another, even by accident.
>
>I'm sure the risks are very clearly outlined to the person taking it.
>
>Renee
>
>Dona wrote:
>>
>> HI Renee you said exactly what I was thinking.I am old enough to
>> remember babies being born with severe birth defects do to Thalidomide
>> in the US and Canada.For those who don't remember it was a drug to
>> prevent morning sickness and babies that were born to these mothers were
>> missing arms,legs and sometimes feet and hands at the end of a tiny
>> stump. I have a friend who is in her early 40's that was effected by
>> this and has no arms and legs.I think our governemnt learned a very hard
>> lesson when it approved Thalidomide so quickly without studying what the
>> outcomes would be of this drug.I am sooo glad my mother refused this
>> drug when it was offered to her when she was pregnant with me!This drug
>> is still on the market and is being used to treat wasting syndrome in
>> HIV patients ,to treat Leporasy, and severe mouth sores there are
>> several other uses as well.It amazes me it is still marketed in this
>> country with the rsks associated with it.
>> Dona
>>
>> At Thu, 15 Nov 2001, Renee wrote:
>> >
>> >Genny,
>> >
>> >Yes, the FDA takes too long. However, sometimes it can go too fast. For
>> >example, Rezulin, Propulsid (or Prevacid, I forget which one was pulled off
>> >the market two years ago), Thalidomide. Sometimes the adverse effects aren't
>> >seen first. If the trial only looks at people over 6 months, is there any
>> >impact with longer use, such as a year, or 5, or 30?
>> >
>> >Does your insurance only cover Met if you're "diabetic?" Your doctor should
>> >be able to write a letter of need explaining why you need it though you're not
>> >diabetic. Or, you can keep with the needle reminders and not stir things up. :-)
>> >
>> >Renee
>> >
>> >"Genny H." wrote:
>> >>
>> >> What is the problem? It is over-regulation. People die every day waiting
>> >> for FDA approval on medications. As a result of the FDA's insistence on
>> >> testing for meds already proven effective and safe, those of us with PCOS
>> >> must be labeled as diabetic so that we can get Glucophage. Once a month I
>> >> get reminders from my pharmacy to come in and get needles and injectable
>> >> insulin, which I neither use or are PXed. This is simply the result of the
>> >> doctor informing my pharmacist that I am diabetic (wink wink nudge nudge).
>> >>
>> >> Genny
>> >>--
>
>--
>Renee Cordrey, MSPT, MPH, CWS
>
>---
>
>Don't follow in the footsteps of the masters. Seek what they sought.
> --Zen saying
>
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